Device recall
Z-1435-2013: Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic…
FDA device recall · Class II · Heart Sync, Inc
Key facts
| Recall number (Z-number) | Z-1435-2013 |
|---|---|
| Recall event | 65085 |
| Product | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. |
| Product code | LDF |
| Recalling firm | Heart Sync, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| 510(k) numbers | K080421 |
| FEI number | 1317188 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database